Altered Cerebral Growth and Development in Infants With Congenital Heart Disease

NCT04233775 | Unknown

• 1 other identifier: Knirsch 01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year. 10% to 15% of cases are born with single ventricle (SV), the most complex type of CHF requiring immediate surgical intervention after birth. Infants with SV CHD are treated in three surgical staged procedures over the first three years of life. However, cerebral injuries occur in around 40% of those children and impact neurocognitive abilities. As more than 90% of all infants with CHD survive to adulthood, scientific concern is focussed on patient-individual course brain growth and development within the relative contribution of fetal, perinatal, cardiac and surgical risk factors. Therefore, serial cerebral MRI examinations are needed, starting (1) at the third trimester during fetal life proceeding to (2) pre- and postoperative time points at the stage I surgery after birth and (3) before stage II surgery at 4 months of age. We will compare the cerebral MRI findings with a healthy control population, recruited at the same time points, and correlate brain growth and development with the neurodevelopmental outcome assessed at one year of age. Three Pediatric Heart Centers in Switzerland and Germany will participate. The overall aims are:

1. 1.To analyse the patient-individual cerebral developmental trajectories, brain growth and determine the time course of brain abnormalities in infants with single ventricle CHD by serial cerebral MRI during fetal life, after birth and at an age of 4 months (primary endpoints).
2. 2.To determine the neurodevelopmental outcome at one year of age using the Bayley III and will be correlated with the brain growth and brain development in the third trimester of fetal life and at the age of 4 months (secondary endpoints).
3. 3.To analyse fetal, neonatal, surgery-related and intensive care associated factors determining the patient-individual course for altered cerebral growth and impaired neurodevelopmental outcome at one year of age.

Conditions

Neurodevelopmental Disorders; Congenital Heart Disease; Brain Injuries; Fetal Growth Retardation

Keywords

congenital heart disease; brain imaging; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• Patient-individual cerebral developmental trajectories

  Brain growth and brain development from third trimester of fetal life to 4 months after birth will be analysed

  6 months

Secondary Outcomes (2)

• Neurodevelopmental outcome at one year of age using the Bayley III

  One year

• Risk factor analysis

  One year

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Fetuses and neonates with complex type of CHD form the study population group. Healthy control population will also be recruited.

You may qualify if:

• All fetuses and neonates with the diagnosis complex type of CHD undergoing open-heart surgery are prospectively enrolled

You may not qualify if:

• a) Clinical evidence or suspicion of a congenital malformation or syndrome, b) brain malformation, c) congenital infection and d) preterms before 37 weeks. These criteria will exclude fetuses and newborns with other conditions that will impact neurodevelopmental outcome.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital

Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• Knirsch W, De Silvestro A, Steger C, Rathke V, Weber R, Von Rhein M, Schneider J, Hutter D, Reich B, Held U, Hackenberg A, Tuura O'Gorman R, Kottke R, Jakab A; BrainCHD Study Group. Serial cerebral magnetic resonance imaging before and after birth in patients with complex congenital heart disease - a prospective, multicentre observational study. Swiss Med Wkly. 2025 Dec 2;155:4466. doi: 10.57187/s.4466.

  PMID: 41397378 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Heart Defects, Congenital; Brain Injuries; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Mental Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walter H Knirsch, MD

  University Children's Hospital, Pediatric Heart Center, Pediatric Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter H Knirsch, MD

CONTACT

+41442667617; walter.knirsch@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)